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draft Value Set Pharmaceutical Dose Form (EDQM) 2021‑06‑01 18:03:30

Id 2.16.756.5.30.1.1.11.3
ref
ch-pharm-
Effective Date 2021‑06‑01 18:03:30
Status draft Draft Version Label 2021
Name PharmaceuticalDoseFormEDQM Display Name Pharmaceutical Dose Form (EDQM)
Description Valueset Pharmaceutical Dose Form from EDQM, PDF, export20.5.2021, see https://standardterms.edqm.eu/#
Source Code System
0.4.0.127.0.16.1.1.2.1 - urn:oid:0.4.0.127.0.16.1.1.2.1
Level/ Type Code Display Name Code System Designations Description
0‑L
10100500
Concentrate for oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain an oral suspension.
0‑L
10101000
Oral drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the solution. The measured dose may be diluted in water or another suitable liquid before swallowing.
0‑L
10102000
Oral drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the suspension. The measured dose may be diluted in water or another suitable liquid before swallowing.
0‑L
10103000
Oral drops, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the emulsion. The measured dose may be diluted in water or another suitable liquid before swallowing.
0‑L
10104000
Oral liquid
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a liquid active substance per se, intended for oral use. Each dose from a multidose container is administered by means of a suitable device such as a measuring spoon.
0‑L
10105000
Oral solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a solution intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
10106000
Oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
10107000
Oral emulsion
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an emulsion intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
10108000
Oral gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation intended for oral use, consisting of a gel, usually hydrophilic, to be swallowed after administration to the oral cavity.
0‑L
10109000
Oral paste
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation intended for oral use, consisting of a paste to be swallowed after administration to the oral cavity.
0‑L
10110000
Powder for oral solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate dissolution in the prescribed liquid. Powders for oral solution include freeze-dried powders. The oral solution is usually prepared just before administration to the patient.
0‑L
10111000
Powder for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate dispersion in the prescribed liquid and to prevent sedimentation during storage of the oral suspension. Powders for oral suspension include freeze-dried powders. The oral suspension is usually prepared just before administration to the patient.
0‑L
10112000
Granules for oral solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dissolution, intended to be dissolved in the specified liquid to obtain an oral solution, which is usually prepared just before administration to the patient.
0‑L
10113000
Granules for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dispersion, intended to be dispersed in the specified liquid to obtain an oral suspension, which is usually prepared just before administration to the patient.
0‑L
10117000
Syrup
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose aqueous preparation characterised by a sweet taste and a viscous consistency and usually containing aromatic or other flavouring agents, intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
10118000
Powder for syrup
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, that may include excipients to facilitate dissolution in water and to obtain the characteristics of a syrup, intended to be dissolved in water to obtain a syrup.
0‑L
10119000
Granules for syrup
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dissolution and to obtain the characteristics of a syrup, intended to be dissolved in water to obtain a syrup.
0‑L
10120000
Soluble tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid before being swallowed.
0‑L
10121000
Dispersible tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet intended to be dispersed in the specified liquid before being swallowed.
0‑L
10121500
Dispersible tablets for dose dispenser
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of small, dispersible tablets that are designed to be used in a dose dispenser, each tablet usually consisting of a small fraction of a dose, with multiple tablets being automatically counted and administered as a single dose.
0‑L
10122000
Herbal tea
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting exclusively of one or more herbal drugs intended for the preparation of an oral aqueous preparation by means of decoction, infusion or maceration. Herbal teas are usually presented in bulk form or in bags. The tea is prepared immediately before oral intake.
0‑L
10201000
Oral powder
0.4.0.127.0.16.1.1.2.1 Single-dose or multidose preparation consisting of one or more particulate solids of varying degrees of fineness. Oral powders are intended for oral administration. They are generally administered in or with water or another suitable liquid, but may also be swallowed directly.
0‑L
10202000
Instant herbal tea
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a lyophilised herbal drug extract intended to be dissolved in water before oral use. Instant herbal teas are supplied in bulk form (multidose) or in sachets (single-dose).
0‑L
10203000
Effervescent powder
0.4.0.127.0.16.1.1.2.1 Solid single-dose or multidose preparation consisting of one or more powders generally containing acid substances and carbonates or hydrogen carbonates that react rapidly in the presence of water to release carbon dioxide. Effervescent powders are intended to be dissolved or dispersed in water before administration.
0‑L
10204000
Granules
0.4.0.127.0.16.1.1.2.1 Solid single-dose or multidose preparation consisting of solid, dry aggregates of powder particles that are sufficiently resistant to withstand handling. Granules are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the active substance(s) (conventional release). They may be swallowed as such and/or chewed before swallowing, and some may also be dissolved or dispersed in water or another suitable liquid before oral administration. Granules for oral solution and Granules for oral suspension are excluded.
0‑L
10205000
Effervescent granules
0.4.0.127.0.16.1.1.2.1 Solid single-dose or multidose preparation consisting of uncoated granules generally containing acidic substances and carbonates or hydrogen carbonates that rapidly react in the presence of water to release carbon dioxide. Effervescent granules are intended to be dissolved or dispersed in water before oral use.
0‑L
10206000
Gastro-resistant granules
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of delayed-release granules intended to resist the gastric fluid and release the active substance(s) in the intestinal fluid. This deliberate modification is achieved by coating the granules with a gastro-resistant material or by embedding the solid particles in the gastro-resistant material. Gastro-resistant granules are usually single-dose preparations intended for oral use.
0‑L
10207000
Prolonged-release granules
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of granules showing a slower release than that of conventional-release granules. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Prolonged-release granules are usually single-dose preparations intended for oral use.
0‑L
10208000
Modified-release granules
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of granules showing a rate and/or place of release different from that of conventional-release granules. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Modified-release granules are usually single-dose preparations intended for oral use, and include prolonged-release, delayed release and pulsatile-release granules. The generic term 'modified-release granules' is used only when the more specific terms 'gastro-resistant granules' or 'prolonged-release granules' do not apply.
0‑L
10209000
Cachet
0.4.0.127.0.16.1.1.2.1 Solid discoid preparation consisting of a wafer enclosing a unit dose intended for oral use.
0‑L
10210000
Capsule, hard
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation contained in a hard shell, the capacity of which can be varied. The shell is made of gelatin or other substances. It consists of two prefabricated cylindrical sections one end of which is rounded and closed, the other being open. The contents of the shell may be a solid or semi-solid preparation, which is filled into one of the sections and closed by slipping the other section over it. Hard capsules are intended for oral use.
0‑L
10211000
Capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation contained in a soft shell, the capacity and shape of which can be varied. The shell is made of gelatin or other substances and may contain (a) solid active substance(s). The shell is thicker than that of hard capsules and consists of one part as soft capsules usually are formed, filled and sealed in one operation. The contents of the shell may be a semi-solid or liquid preparation. Soft capsules are intended for oral use.
0‑L
10212000
Gastro-resistant capsule, hard
0.4.0.127.0.16.1.1.2.1 Solid single-dose, delayed-release preparation contained in a hard shell. The preparation is intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. Hard gastro-resistant capsules are usually made by filling hard capsules with gastro-resistant granules or solid particles made gastro-resistant by coating or, in certain cases, by providing hard capsules with a gastro-resistant shell. They are intended for oral use.
0‑L
10213000
Gastro-resistant capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose, delayed-release preparation contained in a soft shell. The preparation is intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. Soft gastro-resistant capsules are usually formed, filled and sealed in one operation. They may contain a liquid or semi-solid preparation in the gastro-resistant shell. Soft gastro-resistant capsules are intended for oral use.
0‑L
10214000
Chewable capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation contained in a soft shell. The soft capsule is intended to be chewed to release its contents into the mouth. The contents of the soft shell may be a semi-solid or liquid preparation intended for local action or systemic delivery after absorption through the oral mucosa or, when swallowed, in the gastrointestinal tract.
0‑L
10215000
Prolonged-release capsule, hard
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a slower release of the active substance(s) than that of a conventional-release capsule. Prolonged release is achieved by a special formulation design and/or manufacturing method. Hard prolonged-release capsules are intended for oral use.
0‑L
10216000
Prolonged-release capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a soft shell containing a semi-solid or liquid formulation, showing a slower release of the active substance(s) than that of a conventional-release capsule. Prolonged release is achieved by a special formulation design and/or manufacturing method. Soft prolonged-release capsules are intended for oral use.
0‑L
10217000
Modified-release capsule, hard
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Hard modified-release capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term 'modified-release capsule, hard' is used only when the more specific terms 'gastro-resistant capsule, hard' or 'prolonged-release capsule, hard' do not apply.
0‑L
10218000
Modified-release capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a soft shell containing a semi-solid or liquid formulation, showing a rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Soft modified-release capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term 'modified-release capsule, soft' is used only when the more specific terms 'gastro-resistant capsule, soft' or 'prolonged-release capsule, soft' do not apply.
0‑L
10219000
Tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose uncoated preparation obtained by compressing uniform volumes of particulate solids or by other means such as extrusion or moulding. Tablets include single-layer tablets resulting from a single compression of particles and multi-layer tablets consisting of concentric or parallel layers obtained by successive compressions of particles of different composition. Tablets are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of active substance(s) (conventional release).
0‑L
10220000
Coated tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet coated with one or more layers of mixtures of various substances such as sugars and waxes. To the coating colouring matter, flavouring substances and active substance(s) may be added. The thickness of the coating is greater than that of a film-coated tablet. Coated tablets have a smooth surface. They are intended for oral use. When the coating dissolves or disintegrates the active substance(s) is (are) released into the gastrointestinal fluid at a rate depending essentially on its intrinsic properties (conventional release).
0‑L
10221000
Film-coated tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet coated with a thin polymeric film that dissolves within a few minutes in the gastrointestinal fluid. Film-coated tablets are intended for oral use to release active substance(s) at a rate which is not significantly delayed compared to that of the uncoated tablet.
0‑L
10222000
Effervescent tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of an uncoated tablet generally containing acid substances and carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide. Effervescent tablets are intended to be dissolved or dispersed in water before oral use.
0‑L
10223000
Orodispersible tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of an uncoated tablet intended to be placed in the mouth where it disperses rapidly in saliva before being swallowed.
0‑L
10224000
Oral lyophilisate
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation. This fast-releasing preparation is intended to be placed in the mouth where its contents are released in saliva and swallowed or, alternatively, to be dissolved in water before oral administration.
0‑L
10225000
Gastro-resistant tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose, delayed-release tablet intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. These properties are achieved by coating the tablet with a gastro-resistant material or by embedding solid particles in the gastro-resistant material before compression. Gastro-resistant tablets are intended for oral administration.
0‑L
10226000
Prolonged-release tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet showing a slower release of the active substance(s) than that of a conventional-release tablet. Prolonged release is achieved by a special formulation design and/or manufacturing method. Prolonged-release tablets are intended for oral use.
0‑L
10227000
Modified-release tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet showing a rate, a place and/or a time of release different from that of a conventional-release tablet. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Modified-release tablets are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term 'modified-release tablet' is used only when the more specific terms 'gastro-resistant tablet' or 'prolonged-release tablet' do not apply.
0‑L
10228000
Chewable tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of an uncoated tablet intended to be chewed before being swallowed. Chewable tablets are intended for oral administration.
0‑L
10229000
Medicated chewing-gum
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a basis, mainly composed of gums, intended to be chewed but not swallowed. The active substance(s) is (are) released in saliva by chewing. Medicated chewing gum is intended for local treatment of mouth diseases or systemic delivery after absorption through the oral mucosa or from the gastrointestinal tract.
0‑L
10230000
Oral gum
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation with a gum-like consistency, intended to be sucked or chewed before being swallowed. Medicated chewing gum is excluded.
0‑L
10231000
Pillules
0.4.0.127.0.16.1.1.2.1 Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable excipients. Pillules may be prepared by impregnation of preformed pillules with a dilution or dilutions of homoeopathic stocks or by progressive addition of these excipients and the addition of a dilution or dilutions of homoeopathic stocks. Pillules are intended for oral or sublingual use.
0‑L
10236100
Orodispersible film
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended to be placed in the mouth where it disperses rapidly before being swallowed.
0‑L
10301000
Gargle
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended for gargling to obtain a local effect in the oral cavity and the throat. Gargles are not to be swallowed.
0‑L
10302000
Concentrate for gargle
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended to be diluted in water to obtain a gargle.
0‑L
10303000
Gargle, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended to be dissolved in water to obtain a gargle.
0‑L
10304000
Gargle, tablet for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a tablet intended to be dissolved in water to obtain a gargle.
0‑L
10305000
Oromucosal solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a solution intended for oromucosal use.
0‑L
10306000
Oromucosal suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension intended for oromucosal use.
0‑L
10307000
Oromucosal drops
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution, suspension or emulsion intended for oromucosal use. Oromucosal drops are administered by instillation into the oral cavity or onto a specific part of the oral cavity.
0‑L
10308100
Oromucosal spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for oromucosal use. It is administered by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a container with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays are excluded.
0‑L
10308200
Oromucosal spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for oromucosal use. It is administered by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a container with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays are excluded.
0‑L
10308300
Oromucosal spray, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for oromucosal use. It is administered by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a container with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays are excluded.
0‑L
10309100
Sublingual spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.
0‑L
10309200
Sublingual spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.
0‑L
10309300
Sublingual spray, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.
0‑L
10310000
Mouthwash
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended for use in contact with the oral mucosa. It is not to be swallowed. Mouthwashes may contain excipients to adjust the pH which as far as possible is neutral.
0‑L
10311000
Mouthwash, tablet for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of an uncoated tablet intended to be dissolved in water to obtain a mouthwash.
0‑L
10312000
Gingival solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for gingival use.
0‑L
10313000
Oromucosal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a hydrophilic gel intended for oromucosal use. It is applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect. Gingival gel is excluded.
0‑L
10314000
Oromucosal paste
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a paste of solid particles finely dispersed in a hydrophilic basis intended for oromucosal use. Oromucosal pastes are applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect. Gingival paste is excluded.
0‑L
10314005
Oromucosal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid multidose preparation consisting of an ointment intended for oromucosal use. It is applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect
0‑L
10314010
Oromucosal cream
0.4.0.127.0.16.1.1.2.1 Semi-solid, usually multidose preparation consisting of an oil-in-water emulsion intended for oromucosal use. Oromucosal creams are applied to the oral cavity or onto a specific part of the oral cavity, other than the gingivae, to obtain a local effect.
0‑L
10314011
Buccal film
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended to be applied to the buccal cavity (pouch) to obtain a systemic effect.
0‑L
10315000
Gingival gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a gel intended for gingival use to obtain a local effect.
0‑L
10316000
Gingival paste
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a paste of solid particles finely dispersed in a hydrophilic basis intended for gingival use to obtain a local effect.
0‑L
10317000
Oromucosal capsule
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation contained in a soft shell to be chewed or sucked to obtain a local effect in the oral cavity.
0‑L
10317500
Sublingual film
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended for sublingual use to obtain a systemic effect.
0‑L
10318000
Sublingual tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of an uncoated tablet intended for sublingual use. Sublingual tablets are usually prepared by compression of mixtures of powders or granulations into tablets with a shape suited for the intended use. Other technologies such as moulding may be used.
0‑L
10319000
Muco-adhesive buccal tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation to be applied to the buccal mucosa to obtain a systemic delivery over an extended period of time. Mucoadhesive buccal tablets are usually prepared by compression of mixtures of powders or granulations into tablets with a shape suited for the intended use. They usually contain hydrophilic polymers, which on wetting with saliva produce a flexible hydrogel that adheres to the buccal mucosa.
0‑L
10320000
Buccal tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation to be applied to the buccal cavity (pouch) to obtain systemic delivery. Buccal tablets are prepared by compression of mixtures of powders or granulations into tablets with a shape suited for the intended use.
0‑L
10321000
Lozenge
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Lozenges are hard preparations prepared by moulding. They usually contain flavouring and sweetening agents. Lozenges dissolve or disintegrate slowly when sucked.
0‑L
10322000
Compressed lozenge
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation intended to be sucked to obtain a local or systemic effect. It is prepared by compression and is often rhomboid in shape. Compressed lozenges usually contain flavouring and sweetening agents. They dissolve or disintegrate slowly when sucked.
0‑L
10323000
Pastille
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Pastilles are soft, flexible preparations prepared by moulding of mixtures containing natural or synthetic polymers or gums and sweeteners. They dissolve or disintegrate slowly when sucked.
0‑L
10401000
Periodontal powder
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended for administration within the tooth socket/periodontal membrane.
0‑L
10401500
Dental cement
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation intended for application in or on teeth, which subsequently hardens to form a seal or bond.
0‑L
10402000
Dental gel
0.4.0.127.0.16.1.1.2.1 Semi-solid, usually multidose preparation consisting of a hydrophilic gel intended for administration on teeth and gums by rubbing.
0‑L
10403000
Dental stick
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation, rod-shaped and usually prepared by compression or moulding, intended for dental use.
0‑L
10405000
Dental powder
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended for administration on teeth and gums.
0‑L
10406000
Dental solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for administration on teeth and gums.
0‑L
10407000
Dental suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for administration on teeth and gums.
0‑L
10408000
Dental emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for administration on to the teeth and the gums.
0‑L
10409000
Toothpaste
0.4.0.127.0.16.1.1.2.1 Semi-solid, usually multidose preparation consisting of a hydrophilic paste intended to be rubbed onto the teeth.
0‑L
10410000
Periodontal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended to be placed in the pouch between the tooth and the gingiva.
0‑L
10411000
Periodontal insert
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a medicated insert to be placed within the tooth socket/periodontal membrane. The biodegradable insert is a sheet which slowly releases active substance(s).
0‑L
10413000
Powder for dental cement
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended for use in the preparation of a dental cement.
0‑L
10414000
Solution for dental cement
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for use in the preparation of a dental cement.
0‑L
10501000
Bath additive
0.4.0.127.0.16.1.1.2.1 Solid, semi-solid or liquid preparation to be added to the bath water.
0‑L
10502000
Cream
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation of homogeneous appearance consisting of a lipophilic phase and an aqueous phase, one of which is finely dispersed in the other. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic. Creams are intended for cutaneous use. In certain cases, transdermal delivery may be obtained.
0‑L
10503000
Gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable gelling agent, intended for cutaneous use. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic.
0‑L
10504000
Ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying. Ointments are intended for cutaneous use. In certain cases, transdermal delivery may be obtained.
0‑L
10505000
Cutaneous paste
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation containing a large proportion of finely divided solids dispersed in the basis, intended for cutaneous use.
0‑L
10506000
Medicated plaster
0.4.0.127.0.16.1.1.2.1 Flexible single-dose preparation intended to be applied to the skin to obtain, usually, a local effect. Medicated plasters consist of an adhesive basis containing the active substance and spread as a uniform layer on an appropriate support made of natural or synthetic material. The adhesive layer is covered by a suitable protective liner, which is removed before applying the plaster to the skin. Medicated plasters are presented in a range of sizes or as larger sheets to be cut before use.
0‑L
10507000
Cutaneous foam
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation, usually presented in a pressurised container equipped with an applicator suitable for delivery of a foam consisting of large volumes of gas dispersed in a liquid containing active substance(s). Cutaneous foams are intended for cutaneous use.
0‑L
10508000
Shampoo
0.4.0.127.0.16.1.1.2.1 Liquid or, occasionally, semi-solid, usually multidose preparation intended for application to the scalp by rubbing and subsequent washing away with water. Upon rubbing with water, shampoos usually form foam. Shampoos are solutions, suspensions or emulsions containing surface-active agents.
0‑L
10509000
Cutaneous spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation, usually multidose, consisting of a solution in a pressurised container with a spray valve or in a container equipped with a spray pump, intended for cutaneous use.
0‑L
10510000
Cutaneous spray, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension in a pressurised container with a spray valve or in a container equipped with a spray pump, intended for cutaneous use.
0‑L
10511000
Cutaneous spray, powder
0.4.0.127.0.16.1.1.2.1 Solid, usually multidose preparation presented in a pressurised container with a spray valve or in a container equipped with a spray pump. The spray is intended for cutaneous use.
0‑L
10512000
Cutaneous liquid
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for cutaneous use.
0‑L
10513000
Cutaneous solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution of the active substance in a suitable vehicle intended for cutaneous use.
0‑L
10514000
Concentrate for cutaneous solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous solution.
0‑L
10514500
Powder for cutaneous solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a cutaneous solution.
0‑L
10515000
Cutaneous suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension of fine particles in a suitable vehicle intended for cutaneous use.
0‑L
10516000
Cutaneous emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for cutaneous use.
0‑L
10517000
Cutaneous powder
0.4.0.127.0.16.1.1.2.1 Solid, usually multidose preparation consisting of a powder intended for cutaneous use. Cutaneous spray, powder is excluded.
0‑L
10517500
Cutaneous patch
0.4.0.127.0.16.1.1.2.1 Flexible single-dose preparation intended to be applied to the unbroken skin to obtain a local effect by penetration of the active substance(s) into the skin.
0‑L
10518000
Solution for iontophoresis
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended for transdermal delivery by means of iontophoresis.
0‑L
10518500
Powder for solution for iontophoresis
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for iontophoresis.
0‑L
10519000
Transdermal patch
0.4.0.127.0.16.1.1.2.1 Flexible single-dose preparation intended to be applied to the unbroken skin to obtain a systemic delivery over an extended period of time. Transdermal patches consist of a backing sheet supporting a reservoir or a matrix containing the active substance(s) and on the top a pressure-sensitive adhesive, which assures the adhesion of the preparation to the skin. The backing sheet is impermeable to the active substance(s) and normally impermeable to water. In reservoir systems the active substance may be dissolved or dispersed in a semi-solid basis or in a solid polymer matrix, which is separated from the skin by a rate-controlling membrane. The pressure-sensitive adhesive may, in this case, be applied to some or all parts of the membrane, or only around the border of the membrane and the backing sheet. Matrix systems contain the active substance in a solid or semi-solid matrix, the properties of which control the diffusion pattern to the skin. The matrix system may also be a solution or dispersion of the active substance in the pressure-sensitive adhesive. The releasing surface of the patch is covered by a protective liner to be removed before applying the patch to the skin.
0‑L
10520000
Collodion
0.4.0.127.0.16.1.1.2.1 Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol. When applied to the skin, the preparation forms a flexible film on the site of application.
0‑L
10521000
Medicated nail lacquer
0.4.0.127.0.16.1.1.2.1 Liquid preparation to be applied to the nails to form a lacquer by evaporation of the volatile solvent.
0‑L
10522000
Poultice
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a hydrophilic heat-retentive basis in which solid or liquid active substance(s) are dispersed, usually intended to be spread thickly on a suitable dressing and heated before application to the skin.
0‑L
10523000
Cutaneous stick
0.4.0.127.0.16.1.1.2.1 Solid preparation, usually rod-shaped or conical, intended for application to the skin to obtain a local effect. Cutaneous sticks may consist of the active substance(s) alone or dissolved or dispersed in a suitable basis.
0‑L
10525000
Impregnated dressing
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a piece or strip of gauze or other suitable fabric impregnated with a liquid or semi-solid preparation intended for cutaneous use.
0‑L
10546250
Transdermal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable gelling agent. Active substance(s) is (are) dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic. Transdermal gels are intended for transdermal use.
0‑L
10546400
Transdermal solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a solution intended for transdermal use. The term 'Transdermal solution' is used only when more-specific terms such as 'Pour-on solution', 'Solution for iontophoresis', 'Spot-on solution' and 'Transdermal spray, solution' do not apply.
0‑L
10546500
Transdermal spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution in a pressurised container with a spray valve or a container equipped with a spray pump, intended for transdermal use.
0‑L
10547000
Transdermal system
0.4.0.127.0.16.1.1.2.1 Assembly of components intended for transdermal delivery driven by external forces (e.g. electric current, chemical reaction,...). Transdermal patch is excluded.
0‑L
10548000
Solution for skin-prick test
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a skin-prick test.
0‑L
10549000
Solution for skin-scratch test
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a skin-scratch test.
0‑L
10550000
Plaster for provocation test
0.4.0.127.0.16.1.1.2.1 Solid flexible preparation containing an allergen product intended for provocation testing by application to the skin.
0‑L
10600500
Concentrate for solution for intraocular irrigation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular irrigation.
0‑L
10601000
Eye cream
0.4.0.127.0.16.1.1.2.1 Semi-solid sterile single-dose or multidose preparation consisting of a cream intended for ocular use. Eye creams may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the preparation. Eye creams may also be presented in suitably designed single-dose containers. The containers or nozzles of tubes are of a shape that facilitates administration without contamination.
0‑L
10602000
Eye gel
0.4.0.127.0.16.1.1.2.1 Semi-solid sterile single-dose or multidose preparation consisting of a gel intended for ocular use. Eye gels may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the preparation. Eye gels may also be presented in suitably designed single-dose containers. The containers or nozzles of tubes are of a shape that facilitates administration without contamination.
0‑L
10603000
Eye ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid sterile single-dose or multidose preparation consisting of an ointment intended for ocular use. Eye ointments may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the preparation. Eye ointments may also be presented in suitably designed single-dose containers. The containers or nozzles of tubes are of a shape that facilitates administration without contamination.
0‑L
10604000
Eye drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily solution intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
0‑L
10604500
Eye drops, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
0‑L
10605000
Eye drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily suspension intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
0‑L
10608000
Eye drops, solvent for reconstitution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a sterile solvent containing no active substances, intended for reconstitution of a usually freeze-dried powder for eye drops.
0‑L
10609000
Eye drops, prolonged-release
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation intended for ocular use. The active substance is released over an extended period of time.
0‑L
10610000
Eye lotion
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or bathing the eye.
0‑L
10611000
Eye lotion, solvent for reconstitution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a sterile solvent containing no active substances, intended for reconstitution of a usually freeze-dried powder for eye lotion.
0‑L
10612000
Ophthalmic insert
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation of suitable size and shape, designed to be inserted in the conjunctival sac to produce a local or ocular effect by the release of active substance(s) over a determined period of time. Ophthalmic inserts generally consist of a reservoir of active substance(s) embedded in a matrix or bounded by a rate-controlling membrane. They are presented individually in sterile containers.
0‑L
10613000
Ophthalmic strip
0.4.0.127.0.16.1.1.2.1 Solid sterile single-dose preparation consisting of a strip made of a suitable material usually impregnated with active substance(s) intended for use on the eyeball.
0‑L
10701000
Ear cream
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a cream intended for application to the external auditory meatus, if necessary by means of a tampon impregnated with the preparation.
0‑L
10702000
Ear gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a gel intended for application to the external auditory meatus, if necessary by means of a tampon impregnated with the preparation.
0‑L
10703000
Ear ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of an ointment intended for application to the external auditory meatus, if necessary by means of a tampon impregnated with the preparation.
0‑L
10704000
Ear drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an aqueous or oily solution intended for application to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but may also be administered as a small volume.
0‑L
10705000
Ear drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an aqueous or oily suspension intended for application to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but may also be administered as a small volume.
0‑L
10706000
Ear drops, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an emulsion intended for application to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but may also be administered as a small volume.
0‑L
10708000
Ear powder
0.4.0.127.0.16.1.1.2.1 Solid, usually multidose preparation consisting of one or more powders consisting of (a) solid active substance(s) intended for application to the external auditory meatus. Ear powders are presented in containers fitted with a suitable applicator or device for insufflation.
0‑L
10709000
Ear spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for application to the external auditory meatus by spraying to obtain a local effect. Ear sprays are presented in containers with a spray pump or in pressurised containers fitted with a spray valve.
0‑L
10710000
Ear spray, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for application to the external auditory meatus by spraying to obtain a local effect. Ear sprays are presented in containers with a spray pump or in pressurised containers fitted with a spray valve.
0‑L
10711000
Ear spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for application to the external auditory meatus by spraying to obtain local effect. Ear sprays are presented in containers with a spray pump or in pressurised containers fitted with a spray valve.
0‑L
10712000
Ear wash, solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting usually of an aqueous solution with a pH within physiological limits. Ear washes are intended to clean the external auditory meatus.
0‑L
10713000
Ear wash, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting usually of an oil-in-water emulsion with a pH within physiological limits. Ear washes are intended to clean the external auditory meatus.
0‑L
10714000
Ear tampon
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation intended to be inserted into the external auditory meatus for a limited period of time, consisting of a suitable material impregnated with active substance(s).
0‑L
10715000
Ear stick
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation of usually conical shape intended to be inserted in the external auditory meatus where it melts or dissolves.
0‑L
10801000
Nasal cream
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a cream, usually of oil-in-water type, intended for nasal use, usually to obtain a local effect. Nasal creams are usually presented in tubes fitted with a nasal applicator.
0‑L
10802000
Nasal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of usually a hydrophilic gel, intended for nasal use, usually to obtain a local effect. Nasal gels are usually presented in tubes fitted with a nasal applicator.
0‑L
10803000
Nasal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of an ointment, intended for nasal use, usually to obtain a local effect. Nasal ointments are usually presented in tubes fitted with a nasal applicator.
0‑L
10804000
Nasal drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a solution intended for nasal use by means of a suitable applicator.
0‑L
10805000
Nasal drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension intended for nasal use by means of a suitable applicator.
0‑L
10806000
Nasal drops, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an emulsion intended for nasal use by means of a suitable applicator.
0‑L
10807000
Nasal powder
0.4.0.127.0.16.1.1.2.1 Solid, usually multidose preparation consisting of one or more powders of solid active substance(s) intended for nasal use by insufflation into the nasal cavity.
0‑L
10808000
Nasal spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a solution in a container with or without a metering dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.
0‑L
10809000
Nasal spray, suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension in a container with or without a metering dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.
0‑L
10810000
Nasal spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of an emulsion in a container with or without a metering dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.
0‑L
10811000
Nasal wash
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of usually an aqueous isotonic solution intended for cleansing the nasal cavities.
0‑L
10812000
Nasal stick
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation, usually rod-shaped or conical, intended for nasal use, usually to obtain a local effect.
0‑L
10901000
Vaginal cream
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a cream usually presented in a single-dose container provided with a suitable applicator, intended for vaginal use to obtain a local effect.
0‑L
10902000
Vaginal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel usually presented in a single-dose container provided with a suitable applicator, intended for vaginal use to obtain a local effect.
0‑L
10903000
Vaginal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment usually presented in a single-dose container provided with a suitable applicator, intended for vaginal use to obtain a local effect.
0‑L
10904000
Vaginal foam
0.4.0.127.0.16.1.1.2.1 Liquid preparation, usually presented in a pressurised container provided with an applicator suitable for delivery to the vagina of foam containing large volumes of gas dispersed in a liquid containing active substance(s). Vaginal foams are intended for vaginal use, for example for contraception.
0‑L
10905000
Vaginal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for vaginal use by means of a suitable applicator in order to obtain a local effect.
0‑L
10906000
Vaginal suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for vaginal use by means of a suitable applicator in order to obtain a local effect.
0‑L
10907000
Vaginal emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for vaginal use by means of a suitable applicator in order to obtain a local effect.
0‑L
10908000
Tablet for vaginal solution
0.4.0.127.0.16.1.1.2.1 Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a vaginal solution.
0‑L
10909000
Pessary
0.4.0.127.0.16.1.1.2.1 Solid, single-dose preparation usually prepared by moulding, of various shapes, usually ovoid, with a volume and consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature.
0‑L
10910000
Vaginal capsule, hard
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a hard capsule of a size and shape suited for vaginal use, containing a liquid or semi-solid formulation, intended for a local effect.
0‑L
10911000
Vaginal capsule, soft
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a soft capsule of a size and shape suited for vaginal use, containing a liquid or semi-solid formulation, intended for a local effect.
0‑L
10912000
Vaginal tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet, usually uncoated or film-coated, intended for administration to the vagina to obtain a local effect. Vaginal tablets are usually of larger size and a different shape from tablets intended for oral administration.
0‑L
10913000
Effervescent vaginal tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a vaginal tablet usually containing acid substances and carbonates or hydrogen carbonates that react rapidly in the presence of aqueous liquid to release carbon dioxide.
0‑L
10914000
Medicated vaginal tampon
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a suitable material impregnated with active substance(s) intended to be inserted in the vagina for a limited period of time.
0‑L
10915000
Vaginal delivery system
0.4.0.127.0.16.1.1.2.1 Drug delivery system intended to be inserted in the vagina where it releases its contents over an extended period of time. Medicated sponge and medicated vaginal tampon are excluded.
0‑L
11001000
Rectal cream
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a cream usually presented in a single-dose container provided with a suitable applicator, intended for rectal use to obtain a local effect.
0‑L
11002000
Rectal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel usually presented in a single-dose container provided with a suitable applicator, intended for rectal use to obtain a local effect.
0‑L
11003000
Rectal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment usually presented in a single-dose container provided with a suitable applicator, intended for rectal use to obtain a local effect.
0‑L
11004000
Rectal foam
0.4.0.127.0.16.1.1.2.1 Liquid preparation, usually presented in a pressurised container provided with an applicator suitable for delivery to the rectum of foam containing large volumes of gas dispersed in a liquid containing the active substance. Rectal foams are intended for a local effect.
0‑L
11005000
Rectal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for rectal use or for diagnostic purposes. Rectal solutions are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator is provided separately.
0‑L
11006000
Rectal suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for rectal use or for diagnostic purposes. Rectal suspension are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator is provided separately.
0‑L
11007000
Rectal emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for rectal use or for diagnostic purposes. Rectal emulsions are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator is provided separately.
0‑L
11008000
Concentrate for rectal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain a rectal solution.
0‑L
11009000
Powder for rectal solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a rectal solution.
0‑L
11010000
Powder for rectal suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a rectal suspension.
0‑L
11011000
Tablet for rectal solution
0.4.0.127.0.16.1.1.2.1 Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a rectal solution.
0‑L
11012000
Tablet for rectal suspension
0.4.0.127.0.16.1.1.2.1 Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dispersed in the specified liquid to obtain a rectal suspension.
0‑L
11013000
Suppository
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation of a shape, size and consistency suitable for rectal use, containing active substance(s) dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature.
0‑L
11014000
Rectal capsule
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a soft capsule of elongated shape suitable for rectal use, containing a liquid or semi-solid formulation, and which may have a lubricating coating.
0‑L
11015000
Rectal tampon
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a suitable material impregnated with active substance(s) intended to be inserted in the rectum for a limited period of time usually for a local effect.
0‑L
11101000
Nebuliser solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for inhalation use. The solution is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
0‑L
11102000
Nebuliser suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for inhalation use. The suspension is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
0‑L
11103000
Powder for nebuliser suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a nebuliser suspension.
0‑L
11104000
Powder for nebuliser solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a nebuliser solution.
0‑L
11105000
Nebuliser emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for inhalation to obtain local effect or systemic delivery. The emulsion is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
0‑L
11106000
Pressurised inhalation, solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is presented in a pressurised container usually fitted with a metering dose valve.
0‑L
11107000
Pressurised inhalation, suspension
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a suspension intended for inhalation use. The preparation is presented in a pressurised container fitted with a metering dose valve.
0‑L
11108000
Pressurised inhalation, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of an emulsion intended for inhalation use. The preparation is presented in a pressurised container fitted with a metering dose valve.
0‑L
11109000
Inhalation powder
0.4.0.127.0.16.1.1.2.1 Solid, usually multidose preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) to be administered by a dry-powder inhaler containing a metering dose mechanism within the inhaler. 'Inhalation powder, hard capsule' and 'Inhalation powder, pre-dispensed' are excluded.
0‑L
11110000
Inhalation powder, hard capsule
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) enclosed in a hard capsule. The capsule is loaded into a dry-powder inhaler to generate an aerosol.
0‑L
11111000
Inhalation powder, pre-dispensed
0.4.0.127.0.16.1.1.2.1 Solid preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) presented in a suitable pharmaceutical form other than a hard capsule, either in the form of a single dose or divided into multiple single doses. The preparation is loaded into a dry-powder inhaler to generate an aerosol.
0‑L
11112000
Inhalation vapour, powder
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders of solid active substance(s) intended for generation of vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the powder to hot water.
0‑L
11113000
Inhalation vapour, capsule
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a capsule formulation intended for generation of vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the whole capsule or the capsule contents to hot water.
0‑L
11114000
Inhalation vapour, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for generation of vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the solution to hot water.
0‑L
11115000
Inhalation vapour, tablet
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a tablet intended for generation of vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the tablet to hot water.
0‑L
11116000
Inhalation vapour, ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment intended for generation of vapour to be inhaled to obtain a local effect. The vapour may be generated by adding the ointment to hot water.
0‑L
11117000
Inhalation vapour, liquid
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a liquid active substance per se, such as an essential oil or a volatile anaesthetic, intended for generation of vapour to be inhaled. The vapour may be generated by adding the liquid to hot water or by the use of a vaporising device.
0‑L
11201000
Solution for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection.
0‑L
11202000
Suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by injection.
0‑L
11203000
Emulsion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection.
0‑L
11204000
Gel for injection
0.4.0.127.0.16.1.1.2.1 Sterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or organ.
0‑L
11205000
Powder for solution for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection.
0‑L
11206000
Powder for suspension for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a suspension for injection.
0‑L
11208400
Powder for prolonged-release suspension for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a prolonged-release suspension for injection.
0‑L
11208500
Prolonged-release suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a suspension intended for administration by injection
0‑L
11209000
Concentrate for solution for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection.
0‑L
11209500
Solution for cardioplegia
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution intended for use in inducing cardiac arrest during heart surgery. Some preparations may require mixing with other preparations prior to administration, for example to adjust the pH.
0‑L
11210000
Solution for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution intended to be introduced, usually in large volumes, usually into the circulating blood stream.
0‑L
11211000
Emulsion for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced, usually in large volumes, usually into the circulating blood stream.
0‑L
11211500
Powder for dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a dispersion for infusion.
0‑L
11212000
Powder for solution for infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified aqueous liquid to obtain a solution for infusion.
0‑L
11213000
Concentrate for solution for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution intended to be diluted in the specified aqueous liquid to obtain a solution for infusion. It may be added to a solution for infusion during the administration.
0‑L
11216000
Solvent for parenteral use
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a product for parenteral use.
0‑L
11301000
Implant
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation of a size and shape suitable for implantation. It may be prepared by moulding or other means other than compression. Each implant is presented in a sterile container that may be provided with an administration device. Implants are intended for release over an extended period of time in order to obtain local or systemic effect. 'Implantation tablet', 'Implantation chain' and 'Implantation matrix' are excluded.
0‑L
11302000
Implantation tablet
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation prepared by compression of a solid active substance as such or of a formulation thereof into an implant of a size and shape suitable for implantation, usually subcutaneously. Each implantation tablet is presented in a sterile container. Implantation tablets are intended for release over an extended period of time in order to obtain local or systemic effect.
0‑L
11303000
Implantation chain
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of small spheres mounted on a non-degradable thread to form a chain that allows withdrawal of the remainder of the chain after a certain period of action. Each implantation chain is presented in a sterile container. The implantation chain is intended for release over an extended period of time in order to obtain local or systemic effect.
0‑L
11303300
Implantation matrix
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen), usually impregnated with a liquid preparation, intended for implantation in the body. The material may be cut into smaller pieces before implantation, and may be shaped around a tissue (e.g. a bone) or inserted into a medical device that is then implanted. Implantation matrices are intended for release over an extended period of time, usually in order to obtain a local effect. Usually the matrix disappears with time. When the product is packaged as a separate matrix, powder and solvent (or matrix and solution), which are used to prepare the implantation matrix immediately before use, the appropriate combined term should be used
0‑L
11303500
Implantation suspension
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a suspension intended for implantation in the body
0‑L
11401000
Solution for peritoneal dialysis
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution containing electrolytes with a concentration close to the electrolytic composition of plasma and glucose in varying concentrations or other suitable osmotic agents, intended for intraperitoneal use as a dialysis solution.
0‑L
11402000
Solution for haemofiltration
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution containing electrolytes with a concentration close to the electrolytic composition of plasma, intended for parenteral use in haemofiltration. Glucose may be included.
0‑L
11403000
Solution for haemodiafiltration
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution containing electrolytes with a concentration close to the electrolytic composition of plasma, intended for parenteral use in haemodiafiltration. Glucose may be included.
0‑L
11404000
Solution for haemodialysis
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution containing electrolytes with a concentration close to the electrolytic composition of plasma, intended for use in haemodialysis. Glucose may be included.
0‑L
11405000
Concentrate for solution for haemodialysis
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a suitable quality to obtain a solution for haemodialysis. Glucose may be included.
0‑L
11502000
Bladder irrigation
0.4.0.127.0.16.1.1.2.1 Sterile liquid preparation consisting of sterilised water or an aqueous solution intended for irrigation of the urinary bladder.
0‑L
11502500
Intravesical solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended for intravesical use by means of a suitable applicator. 'Bladder irrigation' is excluded.
0‑L
11503000
Powder for bladder irrigation
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in sterile water to obtain a bladder irrigation.
0‑L
11504000
Urethral gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended for urethral use by means of a suitable applicator.
0‑L
11505000
Urethral stick
0.4.0.127.0.16.1.1.2.1 Solid sterile single-dose preparation, usually rod-shaped and of a size adapted to the dimensions of the urethra, intended for insertion into the urethra. They may be prepared by compression or moulding.
0‑L
11601000
Endotracheopulmonary instillation, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous solution intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded.
0‑L
11602000
Endotracheopulmonary instillation, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an endotracheopulmonary instillation solution.
0‑L
11603000
Endotracheopulmonary instillation, suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an aqueous suspension intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded.
0‑L
11701000
Endocervical gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended for endocervical use by means of a suitable applicator.
0‑L
11901000
Intrauterine delivery system
0.4.0.127.0.16.1.1.2.1 Solid single-dose delivery system intended for intrauterine use that releases its contents of active substance(s) over an extended period of time.
0‑L
12101000
Denture lacquer
0.4.0.127.0.16.1.1.2.1 Liquid preparation to be applied to dentures to form a lacquer by evaporation of the volatile solvent.
0‑L
12102000
Anticoagulant and preservative solution for blood
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution to be mixed with extracorporeal blood.
0‑L
12103000
Solution for blood fraction modification
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use in extracorporeal modification of a blood fraction that is returned to the patient following modification.
0‑L
12104000
Wound stick
0.4.0.127.0.16.1.1.2.1 Solid sterile single-dose preparation, usually rod-shaped or conical, consisting of active substance(s) dissolved or dispersed in a suitable basis that may dissolve or melt at body temperature, intended to be inserted into wounds.
0‑L
12105000
Radiopharmaceutical precursor
0.4.0.127.0.16.1.1.2.1 A radionuclide produced for the radio-labelling of another substance prior to administration.
0‑L
12106000
Radionuclide generator
0.4.0.127.0.16.1.1.2.1 A system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and used in a radiopharmaceutical.
0‑L
12107000
Kit for radiopharmaceutical preparation
0.4.0.127.0.16.1.1.2.1 A preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration. The word radiopharmaceutical may be omitted if there is no ambiguity on the radiopharmaceutical nature of the product. Combinations with other standard terms are not recommended.
0‑L
12108000
Gastroenteral solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for administration to the stomach or duodenum by means of a suitable applicator.
0‑L
12110000
Gastroenteral suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for administration to the stomach or duodenum by means of a suitable applicator.
0‑L
12111000
Gastroenteral emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for administration to the stomach or duodenum by means of a suitable applicator.
0‑L
12111500
Intraperitoneal solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for intraperitoneal use. 'Solution for peritoneal dialysis' is excluded.
0‑L
12112000
Solution for organ preservation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution of electrolytes typically at a concentration close to the intracellular electrolyte composition, intended for storage, protection and/or perfusion of mammalian body organs that are in particular destined for transplantation.
0‑L
12113000
Irrigation solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a large-volume aqueous solution intended for irrigation of body cavities, wounds and surfaces, for example during surgical procedures. Irrigation solutions are either solutions of active substance(s), electrolytes or osmotically active substances in water for injections, or they consist of water for injections as such.
0‑L
12114000
Stomach irrigation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution intended for irrigation of the stomach.
0‑L
12115000
Sealant
0.4.0.127.0.16.1.1.2.1 Liquid, more or less viscous, sterile preparation intended for use as tissue glue.
0‑L
12115100
Sealant matrix
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of a pliable piece of material impregnated or coated with a sealant or with a powder that forms a sealant after contact with an appropriate fluid (e.g. blood). It may act as a haemostatic agent and/or tissue glue. The matrix may itself form part of the seal, and is usually absorbed by the body over time.
0‑L
12115200
Sealant powder
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be applied directly onto the intended site (e.g. a lesion) to form a haemostatic agent and/or tissue glue after contact with an appropriate fluid (e.g. blood).
0‑L
12117000
Impregnated pad
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a piece of absorbent material impregnated with a liquid preparation.
0‑L
12117500
Impregnated plug
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a piece of material (e.g. polyethylene), usually porous, in which a liquid, semi-solid or solid preparation is impregnated. Implants, pads, sponges and tampons are excluded.
0‑L
12118000
Living tissue equivalent
0.4.0.127.0.16.1.1.2.1 Cultured, living tissue used for the reconstruction of parts of the body. The tissue may consist of ex vivo expanded cells with an extracellular matrix. Where appropriate, the tissue of origin, such as epidermis, dermis, cartilage or muscle, will need to be stated elsewhere in the product information.
0‑L
12119000
Medicated sponge
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a sponge impregnated with active substance(s)
0‑L
12120000
Intestinal gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended for intestinal use.
0‑L
12130000
Medicated thread
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a biodegradable or non-degradable thread impregnated with active substance(s).
0‑L
12131000
Solution for provocation test
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution containing an allergen intended for provocation testing by the nasal, ocular or bronchial routes.
0‑L
12301000
Medicinal gas, compressed
0.4.0.127.0.16.1.1.2.1 A gas packaged under pressure which is entirely gaseous at - 50 °C.
0‑L
12302000
Medicinal gas, cryogenic
0.4.0.127.0.16.1.1.2.1 A gas which liquifies at 1.013 bar at a temperature below -150 °C.
0‑L
12303000
Medicinal gas, liquefied
0.4.0.127.0.16.1.1.2.1 A gas packaged under pressure, which is partially liquid (gas over liquid) at -50 °C.
0‑L
13001000
Concentrate for concentrate for solution for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a concentrate for solution for infusion, which in turn is intended to be diluted in the specified liquid to obtain a solution for infusion.
0‑L
13002000
Concentrate for nebuliser solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain a nebuliser solution.
0‑L
13003000
Concentrate for oromucosal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain an oromucosal solution.
0‑L
13004000
Concentrate for suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a suspension for injection.
0‑L
13005000
Dispersion for concentrate for dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a dispersion intended for use in the preparation of a concentrate for dispersion for infusion, which in turn is intended to be diluted in the specified liquid to obtain a dispersion for infusion.
0‑L
13006000
Ear drops, powder for suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an ear drops suspension.
0‑L
13007000
Effervescent granules for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of effervescent granules intended to be dispersed or dissolved in the specified liquid, which is supplied in the same packaging, to obtain an oral suspension. Where the granules are intended to be dispersed in water, the term 'Effervescent granules' is used instead.
0‑L
13008000
Emulsion for emulsion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an emulsion intended for use in the preparation of an emulsion for injection.
0‑L
13009000
Endotracheopulmonary instillation, powder for suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an endotracheopulmonary instillation suspension.
0‑L
13010000
Eye drops, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an eye drops solution.
0‑L
13011000
Eye drops, powder for suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an eye drops suspension.
0‑L
13012000
Gas for dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Sterile preparation consisting of a gas that is intended to be mixed with the specified liquid to obtain a dispersion of the gas in the liquid, which is intended for administration by infusion.
0‑L
13013000
Gas for dispersion for injection
0.4.0.127.0.16.1.1.2.1 Sterile preparation consisting of a gas that is intended to be mixed with the specified liquid to obtain a dispersion of the gas in the liquid, which is intended for administration by injection.
0‑L
13014000
Gel for gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended for use in the preparation of a gel for cutaneous use.
0‑L
13015000
Granules for rectal suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dispersion, intended to be dispersed in the specified liquid to obtain a rectal suspension, which is usually prepared just before administration to the patient.
0‑L
13016000
Laryngopharyngeal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for administration to the laryngopharynx for a local effect, other than by spraying.
0‑L
13017000
Laryngopharyngeal spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for spraying onto the laryngopharynx for a local effect.
0‑L
13018000
Matrix for implantation matrix
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen) intended to be used in the preparation of an implantation matrix.
0‑L
13020000
Nasal drops, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a nasal drops solution.
0‑L
13021000
Powder for gel
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain a gel (for cutaneous use).
0‑L
13022000
Powder for dental gel
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain a dental gel.
0‑L
13023000
Powder for dispersion for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a dispersion for injection.
0‑L
13024000
Powder for endocervical gel
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain an endocervical gel.
0‑L
13025000
Powder for endosinusial solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an endosinusial solution.
0‑L
13026000
Powder for gingival gel
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to obtain a gingival gel.
0‑L
13027000
Powder for implantation matrix
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be used in the preparation of an implantation matrix, e.g. by dissolving in the specified liquid to prepare the solution used to impregnate the matrix.
0‑L
13028000
Powder for implantation paste
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders intended to be mixed with the specified liquid or paste to obtain an implantation paste.
0‑L
13029000
Powder for intraocular instillation solution
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an intraocular instillation solution.
0‑L
13031000
Powder for sealant
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a sealant.
0‑L
13032000
Powder for solution for skin-prick test
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for skin-prick test.
0‑L
13033000
Solution for solution for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for injection.
0‑L
13035000
Solvent for...
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an excipient that contains no active substances itself but is intended to be used in the preparation of a pharmaceutical product, e.g. for diluting/dissolving/dispersing the item(s) containing the active substance(s). The term is intended to cover all such excipients, with the particular specifications (e.g. sterility requirements) depending on the final product and its intended use.
0‑L
13036000
Suspension for emulsion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a suspension intended for use in the preparation of an emulsion for injection.
0‑L
13037000
Suspension for oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for use in the preparation of an oral suspension.
0‑L
13039000
Suspension for suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a suspension intended for use in the preparation of a suspension for injection.
0‑L
13040000
Powder for emulsion for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be mixed with the specified liquid to obtain an emulsion for injection.
0‑L
13041000
Endosinusial solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended to be administered to the sinuses to obtain a local effect.
0‑L
13042000
Epilesional solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended to be administered onto a lesion.
0‑L
13043000
Implantation paste
0.4.0.127.0.16.1.1.2.1 Semi-solid sterile preparation containing large proportions of solids finely dispersed in the basis, intended to be implanted in the body for release of the active substance(s) over an extended period of time, usually to obtain a systemic effect.
0‑L
13044000
Intraocular instillation solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended to be instilled as drops into an internal part of the eye.
0‑L
13045000
Intravesical suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a small-volume suspension intended for intravesical use by means of a suitable applicator.
0‑L
13046000
Coated granules
0.4.0.127.0.16.1.1.2.1 Solid preparation intended for oral use, consisting of granules coated with one or more layers of mixtures of various substances that are usually applied as a solution or suspension in conditions in which evaporation of the vehicle occurs. When the coating dissolves or disintegrates any active substance is released into the gastrointestinal fluid at a rate depending essentially on its intrinsic properties (conventional release).
0‑L
13047000
Solution for suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use in the preparation of a suspension for injection.
0‑L
13048000
Granules for suspension for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of granules intended to be dispersed in the specified liquid to obtain a suspension for injection.
0‑L
13049000
Dispersion for injection/infusion
0.4.0.127.0.16.1.1.2.1 Sterile liquid preparation consisting of two or more phases of which at least one is dispersed in the liquid phase, intended for administration by injection or infusion. To be used only when emulsion for injection/infusion is not appropriate. Solid suspension preparations are excluded.
0‑L
13050000
Gas for dispersion for injection/infusion
0.4.0.127.0.16.1.1.2.1 Sterile preparation consisting of a gas that is intended to be mixed with the specified liquid to obtain a dispersion of the gas in the liquid, which is intended for administration by injection or infusion.
0‑L
13051000
Solution for injection/skin-prick test
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a skin-prick test or as an injection (usually intraepidermal)
0‑L
13052000
Powder for solution for injection/skin-prick test
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection/skin-prick test.
0‑L
13061000
Solution for solution for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.
0‑L
13066000
Tablet for cutaneous solution
0.4.0.127.0.16.1.1.2.1 Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified liquid to obtain a cutaneous solution.
0‑L
13076000
Prolonged-release solution for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for administration by injection
0‑L
13077000
Urethral emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for urethral use by means of a suitable applicator.
0‑L
13091000
Emulsion for suspension for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an emulsion intended for use in the preparation of a suspension for injection.
0‑L
13102000
Transdermal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying. Transdermal ointments are intended for transdermal use.
0‑L
13105000
Sublingual powder
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a powder intended for sublingual use.
0‑L
13106000
Oral herbal material
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of whole, broken or fragmented plants or parts of plants in an unprocessed state (herbal drug), intended for oral use without requiring transformation (e.g. dissolution or dispersion in water)
0‑L
13107000
Solution for cardioplegia/organ preservation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of an aqueous solution of electrolytes typically at a concentration close to the intracellular electrolyte composition, intended for inducing cardiac arrest during heart surgery, and for storage, protection and/or perfusion of mammalian body organs that are in particular destined for transplantation.
0‑L
50001000
Chewable/dispersible tablet
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of an uncoated tablet intended either to be chewed before being swallowed, or to be dispersed in the specified liquid before being swallowed.
0‑L
50009000
Concentrate for cutaneous spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous spray emulsion.
0‑L
50009300
Concentrate for dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.
0‑L
50009500
Concentrate for emulsion for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.
0‑L
50009750
Concentrate for intravesical solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain an intravesical solution.
0‑L
50010000
Concentrate for oral solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain an oral solution.
0‑L
50011000
Concentrate for oral/rectal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation intended to be diluted in the specified liquid to obtain an oral/rectal solution.
0‑L
50013250
Concentrate for solution for peritoneal dialysis
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for peritoneal dialysis.
0‑L
50015200
Cutaneous/nasal ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment intended for cutaneous or nasal use.
0‑L
50015450
Cutaneous solution/concentrate for oromucosal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for cutaneous use or intended to be diluted in the specified liquid to obtain an oromucosal solution.
0‑L
50015500
Cutaneous spray, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation, usually multidose, consisting of an emulsion in a pressurised container with a spray valve or in a container equipped with a spray pump, intended for cutaneous use.
0‑L
50016000
Cutaneous spray, ointment
0.4.0.127.0.16.1.1.2.1 Ointment formed at the time of administration from a liquid preparation in a pressurised container with a spray valve or in a container equipped with a spray pump.
0‑L
50017000
Dental paste
0.4.0.127.0.16.1.1.2.1 Semi-solid single-dose or multidose preparation consisting of solid particles finely dispersed in a suitable basis, intended for administration on or inside the tooth or on and/or around the nerves supplying the teeth. Toothpaste is excluded.
0‑L
50017500
Dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase, intended to be introduced, usually in large volumes, usually into the circulating blood stream. To be used only when emulsion for infusion is not appropriate. Solid suspension preparations are excluded.
0‑L
50018000
Ear/eye drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use as ear drops or eye drops.
0‑L
50018500
Ear/eye drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a suspension intended for use as ear drops or eye drops.
0‑L
50019000
Ear/eye ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment intended for auricular or ocular use.
0‑L
50019500
Ear/eye/nasal drops, solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use as ear drops, eye drops or nasal drops.
0‑L
50020200
Ear/nasal drops, suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for use as ear drops or nasal drops.
0‑L
50021000
Emulsion for injection/infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection or infusion.
0‑L
50022000
Endosinusial wash, suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for cleaning the sinuses.
0‑L
50024000
Gargle/mouthwash
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for use as a gargle or a mouthwash.
0‑L
50024500
Gargle/nasal wash
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for use as a gargle or a nasal wash.
0‑L
50026000
Gastro-resistant granules for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of gastro-resistant granules intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension.
0‑L
50029150
Granules for oral/rectal suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of granules intended to be dispersed in the specified liquid to obtain an oral/rectal suspension.
0‑L
50029500
Granules for vaginal solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dissolution, intended to be dissolved in the specified liquid to obtain a vaginal solution, which is usually prepared just before administration to the patient.
0‑L
50030000
Inhalation powder, tablet
0.4.0.127.0.16.1.1.2.1 Solid multidose preparation intended for inhalation use. The dose of inhalation powder is generated from the tablet by a metering mechanism within the inhaler, for example by scraping off a small amount of powder from the tablet.
0‑L
50031000
Inhalation vapour, effervescent tablet
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a tablet usually containing acid substances and carbonates or hydrogen carbonates that react rapidly in the presence of aqueous liquid to release carbon dioxide, intended for generation of vapour to be inhaled to obtain a local effect. The vapour may be generated by adding the tablet to hot water.
0‑L
50032000
Inhalation vapour, emulsion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of an emulsion intended for generation of vapour to be inhaled to obtain a local effect. The vapour may be generated by adding the emulsion to hot water.
0‑L
50033000
Inhalation vapour, impregnated pad
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a piece of absorbent material impregnated usually with a liquid or semi-solid preparation, intended for generation of vapour to be inhaled to obtain a local effect.
0‑L
50033100
Inhalation vapour, impregnated plug
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of an impregnated plug that generates a vapour to be inhaled, for example by the patient inhaling through a device containing the plug, thereby drawing air through or over it and vaporising the active ingredient(s) impregnated therein.
0‑L
50033400
Intravesical solution/solution for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for intravesical use or for administration by injection.
0‑L
50036000
Modified-release granules for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of modified-release granules intended to be dispersed in the specified liquid to obtain a modified-release oral suspension. The generic term 'Modified-release granules for oral suspension' is used only when the more-specific terms 'Gastro-resistant granules for oral suspension' or 'Prolonged-release granules for oral suspension' do not apply.
0‑L
50036050
Mouthwash, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a mouthwash.
0‑L
50036500
Nasal/oromucosal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for nasal or oromucosal application. 'Nasal/oromucosal spray, solution' and 'Nasal spray, solution/oromucosal solution' are excluded.
0‑L
50036700
Nasal/oromucosal spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution in a container with or without a metering dose valve or in a container with a spray pump, intended for nasal or oromucosal use.
0‑L
50037100
Nasal spray, powder for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a nasal spray solution.
0‑L
50037400
Nasal spray, solution/oromucosal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for use as a nasal spray or an oromucosal solution.
0‑L
50037500
Oral drops, granules for solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of granules intended to be dissolved in the specified liquid to obtain an oral drops solution.
0‑L
50037750
Oral drops, liquid
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the liquid. The measured dose may be diluted in water or another suitable liquid before swallowing.
0‑L
50037900
Oral/rectal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for oral or rectal use.
0‑L
50038000
Oral/rectal suspension
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a suspension intended for oral or rectal use.
0‑L
50038500
Oral solution/concentrate for nebuliser solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for oral use or intended to be diluted in the specified liquid to obtain a nebuliser solution.
0‑L
50039000
Oromucosal patch
0.4.0.127.0.16.1.1.2.1 Flexible single-dose preparation intended to be applied to the oral cavity to obtain either a systemic or a local effect by delivering the active substance(s) over a certain period of time, after which it is then removed.
0‑L
50039500
Oromucosal/laryngopharyngeal solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal use. 'Oromucosal/laryngopharyngeal solution/spray, solution' is excluded.
0‑L
50040500
Oromucosal/laryngopharyngeal solution/spray, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal use, presented in a container with an optional spray device to allow administration as a spray.
0‑L
50043000
Powder for concentrate for solution for infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a concentrate for solution for infusion, which must subsequently be diluted before administration as a solution for infusion.
0‑L
50048750
Powder for concentrate for dispersion for infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a concentrate for dispersion for infusion, which must subsequently be diluted before administration as a dispersion for infusion.
0‑L
50049100
Powder for concentrate for intravesical suspension
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a concentrate for intravesical suspension, which must subsequently be diluted before administration as an intravesical suspension.
0‑L
50049200
Powder for concentrate for solution for haemodialysis
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a concentrate for solution for haemodialysis, which must subsequently be diluted before use as a solution for haemodialysis.
0‑L
50049250
Powder for concentrate for solution for injection/infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a concentrate for solution for injection/infusion, which must subsequently be diluted before administration as a solution for injection/infusion.
0‑L
50049270
Powder for dental solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a dental solution.
0‑L
50049300
Powder for epilesional solution
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an epilesional solution.
0‑L
50049500
Powder for implantation suspension
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an implantation suspension.
0‑L
50050000
Powder for intravesical solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an intravesical solution.
0‑L
50050500
Powder for intravesical solution/solution for injection
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an intravesical solution/solution for injection.
0‑L
50051000
Powder for intravesical suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an intravesical suspension.
0‑L
50052000
Powder for oral/rectal suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an oral/rectal solution.
0‑L
50053500
Powder for solution for injection/infusion
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection/infusion.
0‑L
50056000
Prolonged-release granules for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of prolonged-release granules intended to be dispersed in the specified liquid to obtain a prolonged-release oral suspension.
0‑L
50056500
Radiopharmaceutical precursor, solution
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a solution containing a radionuclide produced for the radio-labelling of another substance prior to administration.
0‑L
50057000
Solution for haemodialysis/haemofiltration
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution for haemofiltration.
0‑L
50060000
Solution for injection/infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection or infusion.
0‑L
50061500
Solution for sealant
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for the preparation of a sealant.
0‑L
50073000
Powder for solution for intraocular irrigation
0.4.0.127.0.16.1.1.2.1 Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for intraocular irrigation.
0‑L
50073500
Solution for intraocular irrigation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended for irrigation of one or more internal structures of the eye, for example during surgical procedures.
0‑L
50074000
Solvent for solution for intraocular irrigation
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a solution for intraocular irrigation.
0‑L
50076000
Solvent for solution for infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the preparation of a solution for infusion.
0‑L
50077000
Dispersion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase, intended for administration by injection. To be used only when emulsion for injection is not appropriate. Solid suspension preparations are excluded.
0‑L
50079000
Concentrate for solution for injection/infusion
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion.
0‑L
50081000
Inhalation solution
0.4.0.127.0.16.1.1.2.1 Liquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is presented in a non-pressurised container fitted with a metering dose mechanism. 'Nebuliser solution' and 'Pressurised inhalation, solution' are excluded.
0‑L
50082000
Oral drops, powder for suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain an oral drops suspension.
0‑L
13111000
Powder for vaginal solution
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a vaginal solution.
0‑L
13113000
Intrauterine gel
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of a gel intended for intrauterine use.
0‑L
13115000
Medicinal leech
0.4.0.127.0.16.1.1.2.1 Whole, live, medicinal leech, usually of the Hirudo genus (e.g. Hirudo medicinalis, Hirudo verbana), usually intended to be applied to the skin in order to restore or improve local blood flow or to provide other local effects. After attaching itself to the host, the leech creates an incision in the skin and secretes saliva containing a variety of active substances (e.g. anaesthetics, anticoagulants, anti-inflammatories, vasodilators) that allow it to feed on the blood of the host.
0‑L
13118000
Tablet with sensor
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a tablet intended for oral use, in which one or more ingestible sensors are embedded. The sensor is usually not digested, and is usually intended for use with external diagnostic equipment to which it can transmit data such as physiological and behavioural measurements.
0‑L
13123000
Urethral ointment
0.4.0.127.0.16.1.1.2.1 Semi-solid preparation consisting of an ointment intended for urethral use by means of a suitable applicator.
0‑L
13124000
Medicinal larvae
0.4.0.127.0.16.1.1.2.1 Whole, live, medicinal larvae, usually of a species of fly such as Lucilla sericata (common greenbottle fly), provided in an appropriate container such as a mesh bag, intended to be applied to a wound and covered with an appropriate dressing in order to allow debridement of necrotic tissue over a specified period of time (usually a few days). The larvae secrete enzymes into the wound, liquefying the necrotic tissue, and ingest the resulting material.
0‑L
13126000
Prolonged-release dispersion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase, intended for administration by injection
0‑L
13127000
Sublingual lyophilisate
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation, intended for sublingual use.
0‑L
13128000
Prolonged-release wound solution
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation consisting of a solution intended to be administered onto a wound, including surgical wounds
0‑L
13129000
Nebuliser dispersion
0.4.0.127.0.16.1.1.2.1 Liquid preparation consisting of a dispersion intended for inhalation use. The dispersion is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
0‑L
13133000
Gastro-resistant oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose, delayed-release preparation consisting of a suspension intended for oral use. The preparation is intended to resist the gastric fluid and release the active substance(s) in the intestinal fluid. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
13134000
Prolonged-release oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension intended for oral use, showing a slower release of the active substance(s) than that of a conventional-release oral suspension. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
13135000
Modified-release oral suspension
0.4.0.127.0.16.1.1.2.1 Liquid single-dose or multidose preparation consisting of a suspension intended for oral use, showing a rate, a place and/or a time of release of the active substance(s) that is different from that of a conventional-release oral suspension. This deliberate modification is achieved by a special formulation design and/or manufacturing method. The generic term 'Modified-release oral suspension' is used only when the more-specific terms 'Gastro-resistant oral suspension' or 'Prolonged-release oral suspension' do not apply. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
0‑L
13136000
Gastro-resistant powder for oral suspension
0.4.0.127.0.16.1.1.2.1 Solid preparation consisting of a gastro-resistant powder intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension.
0‑L
13139000
Concentrate for dispersion for injection
0.4.0.127.0.16.1.1.2.1 Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for injection.
0‑L
13140000
Cutaneous/oromucosal solution
0.4.0.127.0.16.1.1.2.1 Non-sterile, liquid preparation consisting of a solution intended for cutaneous or oromucosal use
0‑L
13141000
Oromucosal pouch
0.4.0.127.0.16.1.1.2.1 Solid single-dose preparation consisting of a small bag made of a suitable material containing a preparation such as a powder

Legenda: Type L=leaf, S=specializable, A=abstract, D=deprecated. NullFlavors to appear in @nullFlavor attribute instead of @code. NullFlavor OTH (other) suggests text in originalText.
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